FDA cGMP, EU GMP and ISO 9001 Matrices for a Pharmaceutical Quality System - a GMP roadmap. Compiles the provisions of FDA cGMP, EU GMP and ISO 9001.
Changes in the 23rd Edition:
New Annex 1 (coming into operation on 25 August 2023)
New Annex 21 (in operation since 21 August 2022)
Pharmazeutisches Qualitätssystem FDA GMP Matrix